Phase 2
N=210
Phase 2, Multi-Center Trial of Modafinil for Methamphetamine Dependence
Methamphetamine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00520286 ↗Enrolled (actual)
210
Serious AEs
2.4%
Results posted
Apr 2017
Primary outcome: Primary: Abstinence (Week 1 - 12) — 27; 14; 38; 13 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Modafinil (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute on Drug Abuse (NIDA)
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Abstinence (Week 1 - 12) |
27; 14; 38; 13; 39; 13 | — |
| SECONDARY Reduction of Craving |
32; 10 | — |
Summary
The purpose of this study will be to examine the safety and efficacy of modafinil in increasing number of methamphetamine non-use weeks in subjects with methamphetamine dependence.
Eligibility Criteria
Inclusion Criteria
- Must be between the ages of 18 and 65
- Methamphetamine dependent as defined by DSM-IV criteria
- Must be in good general heath with a history of methamphetamine use at screening
- Must be able to provide written informed consent
- If female and of child bearing potential, must agree to use birth control.
Exclusion Criteria
- Please contact site for more information
Data sourced from ClinicalTrials.gov (NCT00520286). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.